Clinical trials: Validation Studies
Alzheimer Disease, Mild Cognitive Impairment
Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) Test
This observational, cross-sectional study is designed to validate a novel diagnostic test for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (negative or positive), to aid in the…
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia
- Trial name
- REPHRASE (NCT05107882)
- Where
- 7 sites in United States, Canada
- Volunteers
- 466 people, healthy volunteers welcome
- Sponsor
- Optina Diagnostics Inc.
Dietary Habits
PortionSize Study 2 Free-Living Evaluation
The objective is to test the accuracy of the PortionSize™ app and the MyFitnessPal© app at measuring energy and nutrient intake in free-living conditions.
- Trial name
- NCT05166226
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Obstructive Sleep Apnea (OSA)
Level 3 Validation Study
This study will compare the output of a new Level 3 polysomnography system against in-laboratory polysomnography.
- Trial name
- NCT07688603
- Testing
- Comparison 1: Level 1 Polysomnography: Cadwell/Alice, Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Windsor Sleep Disorders Clinic
Colorectal Neoplasms, Digestive System Diseases
Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
The objective of this study is to confirm the sensitivity and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.
- Conditions
- Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer
- Trial name
- NCT01600209
- Where
- 13 sites in United States
- Volunteers
- 674 people, healthy volunteers welcome
- Sponsor
- Exact Sciences Corporation
Hypertension
Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study
Lifelight is a novel, calibration-free, software-only medical device that contactlessly measures pulse rate and blood pressure by measuring remote photoplethysmography (rPPG) signals of a patient's face using a standard…
- Trial name
- NCT06535152
- Testing
- Lifelight, Manual sphygmomanometer
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Xim Limited
Atrial Fibrillation
Electrocardiogram Clinical Validation Study
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device.
- Trial name
- NCT03492554
- Testing
- 1-Lead ECG, 12-Lead ECG
- Where
- 5 sites in United States
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Type 1 Diabetes Mellitus
T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus
Type 1 diabetes is a condition that is caused in part by an abnormality of the immune system which occurs when T cells, which are part of the immune system, damage the insulin secreting cells (islet cells) in the pancreas.
- Trial name
- NCT00212329
- Testing
- T Cell Proliferation and Autoreactivity Assays, Cellular Immunoblot Assays, Tetramer Studies
- Where
- 14 sites in United States, United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hypoxia
Polso SpO2 Accuracy Validation Study
The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT03735329
- Testing
- Diagnostic test of SPO2
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
Healthy Subjects, Chronic Conditions, Multiple
Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device
A single center, single blinded, prospective validation (including extension0 study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements.
- Trial name
- NCT04796181
- Testing
- Neteera 130H
- Where
- 2 sites in United States, Israel
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Neteera Technologies Ltd.
Secondary Caries Around Resin Composite Restorations
Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
This study will be conducted to evaluate the clinical performance and validity of both light-induced fluorescence intraoral camera and laser-induced fluorescence device in comparison to visual-tactile assessment method in…
- Trial name
- NCT04426604
- Testing
- Light induced fluorescence intraoral camera, Laser-induced fluorescence device, Visual-tactile assessment method according to FDI criteria
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cairo University
Body Constitution
Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory
Background: Different people are classified into different physiological constitution types in the Traditional Chinese Medicine (TCM) theory.
- Trial name
- NCT03335306
- Where
- China
- Volunteers
- 6,400 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
Cancer
Development and Validation of a Health-related Quality of Life Instrument
This study aims to develop a health related quality of life (HRQOL) patient reported outcome (PRO) for patients receiving immune checkpoint modulator (ICM) therapy.
- Trial name
- FACT-ICM (NCT02651831)
- Testing
- Focus groups and individual interviews, Questionnaire
- Where
- Canada
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Non Invasive Blood Pressure
Philips Non-Invasive Blood Pressure Validation Study
The purpose of this study is to provide supporting documentation of the blood pressure performance for the Philips EarlyVue VS30 monitor on the intended adult and pediatric population.
- Trial name
- NCT06682312
- Testing
- Non-invasive blood pressure
- Where
- United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
CRC, Advanced Neoplasia
Prospective Clinical Validation of a Novel Multitarget FIT in CRC Screening
The primary goal of the population-based colorectal (CRC) screening is early detection and interception of CRC and its precursors to decrease CRC-related morbidity and mortality.
- Trial name
- mtFIT (NCT05314309)
- Testing
- Comparison of two tests (FIT and mtFIT) in the same bowel movement
- Where
- Netherlands
- Volunteers
- 14,712 people, healthy volunteers welcome
- Sponsor
- The Netherlands Cancer Institute
Osteoarthritis, Knee
A Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension
The purpose of this study is to determine the construct validity of the Canary Tibial Extension's measure of self-selected community walking speed.
- Trial name
- NCT05539326
- Testing
- Performance Clinical Outcome Test
- Where
- 6 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Canary Medical
Healthy
Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073
The aim of the study is to validate the Mean Arterial Pressure (MAP) parameter of Masimo INVSENSOR00073 against the gold standard blood pressure measurements from the arterial line while subject undergo a blood pressure variation…
- Trial name
- NCT06334055
- Testing
- Masimo INVSENSOR00073
- Where
- United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Tobacco Dependence
UW Withdraw From Tobacco Study
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success.
- Trial name
- NCT04969198
- Testing
- Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
- Where
- United States
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Polyp of Colon
Artificial Intelligence (AI) Validation Study for Polyp Detection
Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy
- Trial name
- NCT04378660
- Testing
- Artificial intelligence for polyp detection
- Where
- Belgium
- Volunteers
- 357 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Lung Cancer
LC-NMR Study Biomarkers to Detect Lung Cancer
Lung cancer is the most common cancer in men and the fourth most common cancer in women worldwide. Until today no effective method permits the early detection of lung cancer.
- Trial name
- NCT02024113
- Testing
- Venous blood sample
- Where
- 2 sites in Belgium
- Volunteers
- 646 people, healthy volunteers welcome
- Sponsor
- Hasselt University
Eye Disease
Validation of Computerized Vision-Targeted Quality-of-Life Questionnaires
This study will test and compare computerized and paper versions of eye questionnaires. Questionnaires are used in medicine to gain a better understanding of how a disease can impact a person's quality of life.
- Trial name
- NCT00678860
- Where
- United States
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- National Eye Institute (NEI)